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临床试验/KCT0005151
KCT0005151已完成未知

o-Touch” Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode for Small Hepatocellular Carcinoma (= 3cm): A Prospective multicenter Study

Seoul National University Hospital0 个研究点目标入组 159 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
159

研究概览

简要总结

  1. Final Enrollment Number: 159 Participants:158 Dropped: 6 2. Efficacy: (Local recurrence rates 12 months after treatment ) 3. Adverse Event :2022-11-21 Radio-Frequency Ablation -> 2022.11.23 RUQ pain ->22.11.24 yellowish sputum ->PCD insertion (2022.11.28) : PI determined that this was a complication of RFA. 4. Brief Summary Efficacy (Local recurrence rates 12 months after treatment ) Seoul National University Hospital : 0.77 % (2/259) Samsung Medical Center Hospita: 1.74% (4/230) Chosun University Hospita: 2.74% (2/73)

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 85(Year)(—)
性别
All

入选标准

  • (1) Patients who agreed to the protocol requirements and submitted consent
  • (2) 20 years old-85 years old
  • (3) Child-Pugh Class A or B7
  • (4) Among patients with cirrhosis, patients suspected of having HCC of 1-3 cm in size on MDCT or MRI performed within 60 days, and are going to undergo RFA

排除标准

  • (1) When the number of malignant liver tumors is 2 or more
  • (2) When the maximum size of the tumor exceeds 3 cm (diffuse carcinoma)
  • (3) Patients with previous medical history of liver cancer who have recurrent liver cancer within 2 years
  • (4) When the tumor adheres to the portal vein or hepatic vein of 5 mm or larger
  • (5) When the tumor is not visible even under CEUS-fusion image guidance
  • (6) severe liver failure (Child-Pugh class B8, B9 or C)
  • (7) In case of invasion of hepatic vessels by HCC
  • (8) Severe coagulopathy (if platelet is below 50,000/mm3, INR is over 50% prolongation)
  • (9) When there is metastasis outside the liver
  • (10) A situation where the probability of obtaining appropriate data suitable for the research purpose is very low

研究者

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